Bioanalytics
Boris Gorovits, PhD
VP non-clinical and clinical bioanalysis
Regeneron
Tarrytown, New York
.jpg "Jim Shen, PhD (he/him/his) photo")
Jim Shen, PhD (he/him/his)
Executive Director, Head of Regulated Bioanalysis Operations
Bristol-Myers Squibb
Princeton, New Jersey
Bioanalytical methods are a crucial component of translational science. Translational science seeks to bridge the gap between laboratory research and clinical application, asking critical questions about what can and cannot be translated from non-clinical to clinical settings. One of the major differences between non-clinical and clinical investigations is the approach to analytical strategy, which must be initiated early and continuously developed.
However, several challenges arise at the early stages of a program, including limited information, restricted access to necessary reagents or platforms, unknown regulatory expectations, complex biology, and organizational structures where biomarker support activities are separate from bioanalysis groups. Throughout the life of a program, various factors can change, necessitating a flexible and evolving analytical strategy. Examples include health authority guidelines and expectations, the need to investigate various clinical signals, and changes in indication and patient population.
Examples of the questions that should be asked during the development of a translational support plan will be discussed in the presentation. These are intended to underscore the complexity and need for flexibility in bioanalytical strategies, emphasizing what, when, and whether assessments are required or desired. A decision tree approach can help determine what to assess, taking into account the regulatory landscape and the key opinion leaders involved in decision-making.